FDA Asked to Rein in ‘Get Slim’ Surgery Ads

(WOMENSENEWS)–Danielle Delango expected weight loss surgery to change her life, not take it.

The 25-year-old mother underwent Lap-Band surgery at Lawrence Hospital Center for Advanced Surgery in Bronxville, N.Y., in January 2008.

Allergan, the Irvine, Calif., pharmaceutical giant, produces the Lap-Band, one of the most popular gastric bands on the market. The surgically-implanted device cinches the stomach and severely restricts food intake, making patients feel full quicker.

Lap-Band manufacturers and bariatric surgeons insist the device saves more lives than it takes, but mounting evidence suggests that the dangers of the procedure aren’t adequately known.

On Feb. 16 the Food and Drug Administration lowered the weight requirement for the procedure, expanding Allergan’s potential customer base by 26 million, according to The New York Times. The lower restrictions apply only to those with conditions such as diabetes, which are more threatening when combined with excess weight.

Before the expansion, overweight individuals with a body mass index (BMI) of 40 or above or a BMI of 35 with an existing obesity-related health problem such as diabetes qualified for surgery. Under the new guidelines, prospective patients can qualify with a BMI as low as 30 if an underlying complication is present. A person who is 5 feet 6 inches tall and weighing 186 pounds, for example, has a BMI of 40.

Though Delango suffered from severe constipation after the operation, she couldn’t immediately get a follow-up appointment.

Over the phone, doctors advised her to take laxatives and an enema. Delango collapsed five weeks after her surgery, just days before her scheduled appointment. She suffered a 104 fever due to extreme infection and died six days later on March 3, 2008. Delango’s official cause of death was a "fever of unknown origins followed by Lap-Band."

Joan Delango said her daughter had struggled with her weight since junior high school, but insists she wasn’t heavy enough to qualify for surgery. She is unsure of how her daughter qualified for the surgery, unless her medical records were incomplete or erroneous.

"The tragedy is that she didn’t need the surgery in the first place," said Joan Delango.

Other Women Impacted

Other women have suffered fatal complications from the restrictive–and increasingly popular–weight loss procedure.

"I feel strongly that it’s a bad procedure and there’s too much risk even with the most knowledgeable and compliant of patients," said Karen Parks, whose 38-year-old daughter, Leslie, died just three weeks after getting the surgery in Houston.

In view of the complications associated with the Lap-Band, some health officials criticize any marketing that promotes the procedure without serious disclaimers about the associated risks.

A 2007 study funded by Allergan and published in the American Journal of Surgery found that up to 76 percent of patients developed complications over three years. While some deaths are directly related to surgery, many more are connected to Lap-Band failure over time.

In Southern California numerous 1-800-GET-THIN billboards, some featuring a slender woman in a bikini, are produced by a marketing company that directs prospective patients to surgical centers that use the Lap-Band weight loss device.

Ana Renteria, 33, suffered a severe infection and died 10 days after getting the Lap-Band, and 52-year-old Tamara Walter stopped breathing two hours after surgery and was taken off life support four days later. (Walter’s death is not officially attributed to the Lap-Band.)

Both underwent the procedure at the Beverly Hills Surgery Center, one of 11 Southern California weight loss facilities where prospective clients are referred to when they call 1-800-GET-THIN.

"My clients are fully dedicated to providing the highest level of patient care and safety. An overwhelming majority of individuals have experienced positive results which all prior reports have failed to mention," said attorney Robert Silverman, who represents 1-800-GET-THIN and the Beverly Hills Surgery Center. "In full consideration of all of these factors and others, independent review will confirm that not all of these incidents are related to the Lap-Band or the safety of the facilities and doctors providing this service."

Billboards May Not Meet Government Regs

Los Angeles Department of Public Health Director Jonathan E. Fielding has asked the Food and Drug Administration to determine whether advertisements such as the 1-800-GET-THIN billboards prevalent in some parts of Southern California are consistent with government regulations that require consumers to have adequate information about potential surgical risks.

"The Lap-Band procedure, like other bariatric procedures, while effective for many patients, can cause serious complications," Fielding said in a press statement on Jan. 27.

Fielding said that marketing information doesn’t adequately convey the potential complications or make clear that surgery isn’t appropriate for the vast majority of individuals.

The marketers behind the 1-800-GET-THIN billboards are just one of a handful of companies that promote the surgery with language that could also be used to shill the latest fad diet.

Newer billboards have a disclaimer at the bottom, according to attorney Silverman. "We only work with pre-screened, fully inspected and accredited facilities," the billboards state, along with a gold seal with the words, "We are committed to patient safety at the highest level."

Allergan’s Chief Executive Officer David E.I. Pyott distanced his company from the independently-produced billboards.

On Feb. 3, he told the Los Angeles Times he doesn’t support the ad campaign and that Allergan is in the process of devising guidelines for surgeons that require the risks associated with gastric banding be stated clearly on any advertisement.

Since its FDA approval in 2001, gastric banding has been aggressively marketed as a safer and more effective alternative to gastric bypass, its weight loss surgery predecessor.

Magic With Numbers

Dr. Edo Aarts, a bariatric researcher from Rijnstate Hospital in the Netherlands is skeptical.

"Everybody is doing magic with numbers here," he told Women’s eNews in a recent phone interview.

Only deaths that occur within 30 days of surgery figure into statistical mortality rates, Aarts said. That doesn’t count patients such as Delango, whose initial complications turn fatal weeks or even months after the surgery.

Even deaths within a 30-day period aren’t necessarily attributed to the Lap-Band. Deaths from sepsis, cardiac arrest or electrolytic imbalance could be from Lap-Band complications, but coroners’ reports don’t always pin the cause of death on the device, further skewing statistics, Aarts said.

The death rate also doesn’t account for patients lost to follow up–and therefore the ones who don’t receive any post operative-care, who Aarts says tend to fare the worst–and those who get the procedure done out of the country to avoid insurance company red tape and long waiting periods.

Advocates for gastric banding say that as with any surgery, the Lap-Band carries inherent risk and complications that are more likely when patients don’t comply with strict diet and lifestyle changes. Those opting for "surgery mills," or unaccredited surgical centers, also put themselves at risk.

The safe route, according to bariatric professionals, is hospitals and surgical centers sanctioned as "centers of excellence" that meet requirements outlined by the American Society for Metabolic and Bariatric Surgery. Bariatric centers must have a mortality rate of less than 1 percent and provide proper follow-up care to be deemed excellent.

Some "excellence" centers, however, perform up to 20 operations a day and the sheer number of patients makes it difficult for many–like Delango, who was operated on at a hospital that met American Society for Metabolic and Bariatric Surgery criteria–to get quick appointments for adequate follow-up care.

There is no exact science in figuring out how the body will react to a foreign device cinching an essential organ, said Aarts, making it difficult to determine who will react negatively to surgery.

Rep. Chris Smith, a New Jersey Republican, is expected to propose legislation that would permanently impose the Mexico City Policy, which has been a political flashpoint for three decades. United Nations health programs are a target too.

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Brand new lap band surgical procedure guidelines have been issued by the Food and drug administration. Lap band studies certain the Food and Drug Administration to suggest that patients with a lower body mass index than was recommended before ought to be considered eligible if they have health issues linked to obesity. About 26 million more overweight Americans could be more effortlessly approved for lap band surgical procedure under new FDA recommendations.

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It is being hailed as the most progressive state policy so far, going further than New Jersey, California and Rhode Island in various respects. But its showcase potential won’t be tested until the program gets going in 2018.